NDC codes

FDA NDC Directory
Product NDC (as listed)82605-006Labeler and product segments. Claims need a package NDC.
Product NDC at billing width82605-0006Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
82605-006-01826050006012138 L in 1 CYLINDER (82605-006-01)Marketed from Aug 4, 2023
82605-006-0282605000602362 L in 1 CYLINDER (82605-006-02)Marketed from Aug 4, 2023

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Ulspira
Generic name (nonproprietary)
ulspira
Active ingredients
Nitric oxide.8 mL/100L
Dosage form
Gas
Route
Respiratory (Inhalation)
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 203144
Marketing start
Listing expires
Other FDA classes
Vasodilation (Physiologic effect)
Identifiers
Product ID 82605-006_3a136eac-7cc3-31ea-e063-6294a90afb91SPL ID 3a136eac-7cc3-31ea-e063-6294a90afb91SPL set ID 026e4541-63fa-aebc-e063-6294a90abaeaRxCUI 582608UNII 31C4KY9ESHUPC 0082605006021, 0082605006014
Pharmacologic class
Vasodilator

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N482605000601 followed by a unit qualifier and the quantity

Package 82605-0006-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

ULSPIRA™ is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents. ULSPIRA is a vasodilator indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near- term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 203144

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 203144
ProductStrengthForm · routeLabelerProduct NDC
Ulspiranitric oxideNitric oxide .8 mL/100LGasRespiratory (Inhalation)Airgas Therapeutics, LLC82605-008

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free Med-Code account to keep looking up NDCs, J-codes and drugs.

Create a free accountLog in